ISO 13485:2016
Medical Devices Quality Management System Certification - The international standard for quality management systems in the medical device industry.
Benefits of ISO 13485
Quality Assurance
Ensure consistent quality in medical device manufacturing and related services.
Regulatory Compliance
Meet international medical device regulations and standards.
Risk Management
Implement effective risk management in medical device production.
Market Access
Gain access to global medical device markets with recognized certification.
Key Features
Risk-based Approach
Comprehensive risk management throughout the product lifecycle.
Process Validation
Validation of processes for medical device production and sterile products.
Design Controls
Systematic approach to medical device design and development.
Regulatory Compliance
Alignment with medical device regulations worldwide.
Implementation Process
Gap Analysis
Evaluate current quality management system against ISO 13485 requirements.
Documentation
Develop required documentation and quality management procedures.
Risk Management
Implement risk management processes for medical devices.
Validation
Validate processes and equipment for medical device production.
Certification
Complete certification audit process.
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